Boston Therapeutics, Inc., an innovator in designing drugs that address diabetes using complex carbohydrate chemistry, has started enrolling patients in a phase IIb clinical study on PAZ320, a complex carbohydrate-based drug designed to reduce the elevation of post-meal blood glucose by blocking the action of carbohydrate-hydrolyzing enzymes.
A total of 24 patients with type 2 diabetes currently being treated with metformin will be administered PAZ320 under double-blind, placebo-controlled conditions. Patients' blood glucose will be monitored using continuous glucose monitors (CGM) and their postprandial (after-meal) blood glucose levels will be measured following a test meal. The primary endpoint of the study is the evaluation of the effect of PAZ320 compared to placebo in the area under the curve (AUC) of glucose and on insulin levels in the blood for four hours following intake of the meal. The study is being conducted at Centre Hospitalier Robert Bisson, Lisieux, France.
David Platt, Ph.D., chief executive officer, Boston Therapeutics, said, "This trial is designed to build upon the positive results from our Dartmouth Medical Centre phase IIa trial for PAZ320, recently published in the peer-reviewed journal, Endocrine Practice. In the phase IIa study, PAZ320 was well tolerated in patients taking various anti-diabetic agents, including metformin. The phase IIb trial, which focuses on patients taking only metformin, is the next step in the investigation of this compound as a potential adjunct to metformin in patients living with type 2 diabetes. We believe it is important to better control glucose levels throughout the day, given the many complications that stem from uncontrolled diabetes."
Metformin is the most widely prescribed drug for diabetes and often the first drug prescribed to newly diagnosed diabetes patients.
PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. PAZ320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
Boston Therapeutics is focused on developing and commercializing therapeutic molecules that address type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes.